title: A prospective randomized trial of catheter-directed thrombolysis with additional balloon dilatation for iliofemoral deep venous thrombosis: a single-center experience.
abstract: OBJECTIVE
  Catheter-directed thrombolysis (CDT) is effective for acute iliofemoral deep venous thrombosis (DVT), but CDT remains partially effective for subacute DVT. The aim of this study was to conduct a prospective randomized controlled single-centre clinical trial to compare CDT alone with CDT with additional balloon dilatation for the treatment of iliofemoral DVT.
  
  
  METHODS
  The trial was performed between February 2007 and January 2011. Iliofemoral DVT patients lacking effective therapy before enrollment were randomly assigned either to CDT (control group) or to CDT with additional balloon dilatation (intervention group). Insufficiency Epidemiological and Economic Study-Quality of Life (VEINES-QOL), Severity of Venous Lower Limb Symptoms (VEINES-Sym), 36-Item Short-Form Health Survey (SF-36), and Villalta scores were obtained at scheduled follow-up.
  
  
  RESULTS
  Seven hundred twenty-two patients were screened, and 386 eligible patients were randomized. No significant difference for mean total Villalta score was observed between the intervention group (4.20 ± 3.05) and the control group (4.89 ± 3.45). However, post hoc analysis of the scores in subacute patients showed significant differences between the intervention group and the control group from 1 month (6.79 ± 4.23, 8.28 ± 5.03, P = 0.02) to 24 months (4.21 ± 3.08, 5.67 ± 3.71, P = 0.006). A significant difference was also observed in subacute patients at the end of follow-up for VEINES-QOL/Sym (52.87 ± 6.52, 50.31 ± 6.07, P = 0.009; 51.87 ± 6.37, 49.72 ± 5.96, P = 0.02) and SF-36 PCS/MCS (45.02 ± 12.07, 41.13 ± 11.68, P = 0.03; 53.26 ± 11.43, 49.50 ± 11.06, P = 0.03).
  
  
  CONCLUSIONS
  Subacute iliofemoral DVT patients lacking effective therapy during acute phase, might receive more benefits from CDT with additional balloon dilatation. However, CDT alone is highly effective for acute patients.
authors.affiliation: Department of Vascular Surgery, Second Affiliated Hospital, Chongqing Medical University, 76 Linjiang Rd, Yuzhong District, Chongqing, 400010, People's Republic China, zxq534799859@163.com.
authors.forename: Xiaoqin
authors.initials: X
authors.lastname: Zhang
authors.forename: Qingshuai
authors.initials: Q
authors.lastname: Ren
authors.forename: Xuemei
authors.initials: X
authors.lastname: Jiang
authors.forename: Jianming
authors.initials: J
authors.lastname: Sun
authors.forename: Jianping
authors.initials: J
authors.lastname: Gong
authors.forename: Bo
authors.initials: B
authors.lastname: Tang
authors.forename: Yikuan
authors.initials: Y
authors.lastname: Chen
mesh_terms: D000800:Angioplasty, Balloon; D002406:Catheterization, Peripheral; D005260:Female; D005268:Femoral Vein; D006801:Humans; D007084:Iliac Vein; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D012720:Severity of Illness Index; D015912:Thrombolytic Therapy / Q000379:methods*; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000628:therapy*